Confident your medical device business is compliant? How Sage can help.
This article looks at how companies that make and sell medical devices can stay ahead of the curve when it comes to compliance, by adopting better business systems.
Medical and dental clinics, hospitals, diagnostic services, and pharmacies are essential to the everyday health and wellbeing of Australians. A 2018 report by the Grattan Institute states that more than 20 million Australians use more than 400 million primary care services across 20,000 organisations each year.
An expanding and ageing population means demand for high-quality care will continue to increase. Spending on health in Australia has grown by about 50 percent in real terms over the past decade. Hospitals and primary health account for about three-quarters of all health spending.
Companies that manufacture and sell medical equipment and supplies are well-placed for growth, in order to meet the needs of this market.
A coordinated approach is key to growth for medical device manufacturers
The devices and materials that GPs, doctors, nurses, dentists, and allied health professionals use, and medical equipment sold in pharmacies, must be safe and effective. Lives depend on it.
Whether it’s a high-end MRI machine or a syringe—it must work as intended. The instruments and materials used by health professionals within clinics, hospitals, and patients’ homes are vital for the effective diagnosis, monitoring and treatment of conditions.
In such a high-risk industry, remaining competitive in the long-term will hinge on your ability to demonstrate quality and transparency at every stage.
Not meeting your compliance obligations is not an option—but you also need to manage the day-to-day complexity of running a business including meeting customer expectations, efficient production, and cost-effective inventory management.
It follows that mid-sized manufacturers and wholesale distributors of medical equipment and supplies need high-level visibility made possible through an integrated business management system.
Sage X3/Enterprise Management is an Enterprise Resource Planning (ERP) solution that beautifully supports compliance and traceability needs while delivering a whole-of-business performance boost.
Are you doing enough to prepare for increased regulatory scrutiny?
Avoiding product recalls and maintaining regulatory compliance are some of the top challenges globally for medical device manufacturers.
Australia has strict regulatory requirements. It creates an environment that favours local manufacturers and distributors over international competitors, but also adds pressure to develop exceptionally reliable processes and record-keeping.
Devices approved for use are entered into a national database maintained by the Therapeutic Goods Administration (TGA) so that practitioners and patients alike can ensure they are safe and meet a certain standard for performance.
Recent reforms to the industry include an ‘Action Plan for Medical Devices’ released earlier this year designed to:
- Improve how new devices get on the market.
- Strengthen the monitoring and follow-up of devices in use.
- Provide more detail to patients.
- Increase public confidence in medical devices and their regulation.
Changes being considered may add more rigour or requirements for evidence in the assessment of devices, plus introduce new systems to identify and act on problems with medical devices.
For instance, the TGA will work with healthcare facilities to “…find ways to increase rapid information sharing about medical device safety and effectiveness.” This could include mandatory reporting of adverse events.
Sage X3 gives you complete control so you can deliver for your healthcare clients
Medical device manufacturers and distributors need oversight of all parts of their operation and every product as it moves through the value chain.
Sage X3/Enterprise Management is a robust ERP solution that will help your business coordinate product data, production, testing, traceability, processes, and information flows in ways that support you to capably manage your certifications.
The journey to a more confident and compliant business starts with robust business systems. Sage X3/Enterprise Management includes the following valuable tracking features:
- Upstream and downstream traceability: Apply batch, sub-batch, and serial numbers; manage quality control records and procedures; run reports by batch or component to quickly locate and inform affected customers/suppliers when problems arise.
- Versioning: A product may have evolved over time, with multiple versions that include slightly different components or production processes. Because you can allocate versions in Sage X3/Enterprise Management it’s straightforward to identify the exact product affected in case of returns/recalls.
- Service and maintenance records: Sage X3/Enterprise Management can keep track of equipment that is sold to enable you to manage after-sale service and maintenance, including transferring ownership records to new facilities/patients if a piece of equipment is on-sold. This helps you manage client relationships and traceability over the long-term.
Sage X3/Enterprise Management is ideal for medical device and supplies manufacturers and wholesale distribution companies. Consider Sage’s ERP if you want to improve how your business manages the quality and safety of products from end-to-end across procurement, production, sales, distribution and servicing processes.
Leverage Technologies is an experienced ERP implementation partner. We understand the Australian business landscape and how Sage X3/Enterprise Management is best applied. Talk to a consultant now.
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